Treatment of Distal Radius Fractures in Elderly Patients

April 7, 2011 updated by: Hand and Upper Limb Clinic, Canada

Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial

The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

  • Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment.
  • Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year.
  • Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A4L6
        • Hand and upper Limb Centre
      • London, Ontario, Canada, N6A5L8
        • Hand and upper Limb Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Distal Radius Fracture
  • Between 10 and 20 degrees of dorsal angulation
  • Between 3 and 5mm of Ulnar positive variance
  • Between 1 and 2mm intra Articular Step deformity
  • Age 65 and older

Exclusion Criteria:

  • Pre-Morbid medical conditions which preclude surgical intervention
  • Patients who do not live independently.
  • Patients with an open fracture
  • Associated soft tissue or skeletal injury to the same limb.
  • Pre-existing wrist arthrosis or disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgery
Surgical intervention to reduce Distal Radius Fracture
Procedure: Distal Radius Fracture Reduction
Surgical Intervention to Reduce Distal Radius Fracture
Other Names:
  • Distal Radius Reduction
Other: Conservative Treatment
Conservative treatment of Distal Radius Fractures
Other: Conservative Management
Conservative management of Distal Radius Fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE).
Time Frame: 0-1 year
0-1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary: To determine if other baseline factors influence outcome. For example, baseline activity levels (RAPA), home supports, hand dominance, and general mental health will be analyzed.
Time Frame: over 1 year
over 1 year
Secondary: To stratify results by age. (65-75, 77-80, and >80)
Time Frame: 0-1 year
0-1 year
Grip strength, Range of Motion and Dexterity testing of wrists
Time Frame: 3 months to 12 months
3 months to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hand and Upper Limb Clinic, Canada

Collaborators

LHRI- Lawson Health Research Institute

Investigators

  • Principal Investigator: Joy C MacDermid, PhD, Hand and Upper Limb Centre, St. Joseph's Health Care
  • Principal Investigator: Ruby Grewal, MD, FRCSC, Hand and Upper Limb Centre, St Joseph's Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 11, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LHRI 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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